DUPIXENT was studied in children aged 6–11 years old with uncontrolled moderate-to-severe* asthma vs placebo1

The VOYAGE study was a randomised, double-blind, placebo-controlled phase 3 study designed to
demonstrate the efficacy and safety of DUPIXENT over a period of up to 52 weeks in children 6 – 11
years of age with uncontrolled moderate-to-severe* asthma. Patients were split into two primary
efficacy populations.1

Patients with a blood eosinophil count of at least 300 cells per cubic millimetre at baseline

Patients with the Type 2 inflammatory asthma phenotype (defined as a blood eosinophil count of ≥150 cells per cubic millimetre or a FeNO of ≥20 ppb at baseline)
 

 

Recruited patients were required to have a history of steroid use, severe exacerbations, and reduced lung function1

Asthma exacerbations:1

2-3

mean annualised exacerbations
 

Lung function:3

<80%

mean % predicted pre-
bronchodilator (BD) forced
expiratory volume in 1 second (FEV1) 

Asthma control:1

2.2

mean 7-item Asthma Control
Questionnaire Interviewer
Administered (ACQ-7-IA) score†

Quality of life:2

~5

mean Paediatric Asthma Quality of Life Questionnaire with Standardised Activities – Interviewer Administered (PAQLQ(S)-IA) score‡

THE DUPIXENT PRE-FILLED SYRINGE


 

Adult and adolescent trial design

Learn more about how the clinical trials have been designed.



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Safety profile

Learn more about the safety profile of DUPIXENT.



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Exacerbations and lung function

DUPIXENT can improve exacerbations and lung function of 12+ years old patients with severe asthma

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    *Some patients in this study classed as having severe asthma no longer fall into this category, owing to changes in the definition of high-dose ICS
    † Scores on the Asthma Control Questionnaire 7 Interviewer-Administered (ACQ-7-IA) range from 0 (totally controlled) to 6 (severely uncontrolled); a change of 0.5 is considered to be clinically important.‡
    Pediatric Asthma Quality of life Questionnaire with standardised Activities-Interviewer Administered 23 questions in 3 domains(symptoms, activity, limitation, and emotional functions); a change of 0.5 is considered to be clinically important.

    References

    1. Bacharier LB, et al. 2021 N Engl J Med;385(24):2230-2240. doi:10.1056/ NEJMoa2106567
    2.  Data on file, Sanofi US. LIBERTY ASTHMA VOYAGE. CSR. 2020. 3.
    3.  Juniper EF, et al. Eur Respir J 2010;36(6):1410-1416. doi:10.1183/09031936.00117509.
    4.  Poachanukoon O, et al. Pediatr Allergy Immunol 2006;17(3):207-212. doi:10.1111/j.1399-3038.2005.00349

MAT-XU-2204213 (v1.0) | Date of preparation: April 2023